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Effects of Cardiopulmonary Bypass (CPB)-Leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function (PulmFunction)

This study has been completed.
Sponsor:
Collaborators:
InCor Heart Institute
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Maria José Carvalho Carmona, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01469676
First received: June 22, 2011
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

To test the hypothesis that leukocyte filtering during cardiopulmonary bypass (CPB) might reduce the inflammatory response and protect the lungs against the acute injury


Condition Intervention
Systemic Inflammatory Response Syndrome (SIRS)
Leukocyte Disorders
Complications Due to Coronary Artery Bypass Graft
 Device: Filtering group LG-6, Pall Biomedical Products

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    The primary outcome was the evaluation of the effects of leukocyte filtration on lung function in patients undergoing coronary surgery.


Secondary Outcome Measures:
  • Evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    The secondary outcome was the evaluation of the effects of leukocyte filtration on the inflammatory response in patients undergoing coronary surgery.


Enrollment: 22
Study Start Date: February 2007
Study Completion Date: October 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
In the Control group, a standard arterial line filter was inserted on CPB circuit.
Experimental: Filtering Group
In the Filtering group, a leukocyte filter was inserted in the arterial line circuit.
 Device: Filtering group LG-6, Pall Biomedical Products
In Filtering group, a Leukocyte filter (LG-6, Pall Biomedical Products) was placed on the CPB arterial line circuit, trying to filter the white blood cells.
Other Names:
  • LeukoGard-6
  • Leukocyte depletion
  • Leukoreduction

Detailed Description:

BACKGROUND AND OBJECTIVES: The extension of the systemic inflammatory response observed after cardiopulmonary bypass (CPB) in cardiac surgery is associated to postoperative pulmonary dysfunction degree. The leukocyte depletion during CPB can modify that response. The aim of this study was to evaluate the effects of leukocyte filtering on the inflammatory response and lung function in patients undergoing coronary artery bypass grafting.

METHODS: After approval by the institutional ethical committee, a prospective randomized study was performed to compare nine patients undergoing coronary artery bypass grafting (CABG) using leukocyte filtration in the arterial line (LG-6, Pall Biomedical Products) and eleven others submitted to standard CPB. Chest CT, oxygenation analysis and a complete leucocyte count were performed before surgery. After intravenous anesthesia induction, patients were mechanically ventilated with tidal volume of 8 mL.kg-1, with FiO2 0.6, and PEEP of 5 cm H2O, except during CPB. Haemodynamic data, PaO2/FiO2, shunt fraction, interleukins, elastase and myeloperoxidase were evaluated before and after CPB, at the end of surgery, 6, 12 and 24 hours after surgery. Chest CT was repeated on the first postoperative day. Data were analyzed using two-factor ANOVA for repeated measures.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing coronary artery bypass grafting (CABG), having their physical state classified as PII and PIII, according to the American Society of Anesthesiologists (ASA). Surgical risk was stratified according to Parsonnet criteria, and only patients considered low to moderate risk were admitted.

Exclusion Criteria:

  • Subjects older than 70 years
  • Body mass index (BMI) over 35 kg/m2
  • Congestive heart failure (CHF) greater than class III (NYHA)
  • Left ventricle ejection fraction less than 40%
  • Submitted to recent surgery
  • creatinine ≥ 1.4 mg / dL or in use of oral anticoagulants were excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469676

Sponsors and Collaborators
University of Sao Paulo
InCor Heart Institute
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Maria José C Carmona, phd U Sao Paulo
  More Information

No publications provided

Responsible Party: Maria José Carvalho Carmona, Effects of CPB-leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01469676     History of Changes
Other Study ID Numbers: Leukocyte Filtration
Study First Received: June 22, 2011
Last Updated: November 9, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:
Coronary Artery Bypass Surgery
Cardiopulmonary Bypass
Leukocyte Reduction Filtrations
Pulmonary Function
Systemic Inflammatory Response

Additional relevant MeSH terms:
Leukocyte Disorders
Systemic Inflammatory Response Syndrome
Hematologic Diseases
 Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on May 16, 2013